This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and efficacy of daily treatment.
This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and efficacy of daily treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Oral capsules
KaRa MINDS
Macquarie Park, New South Wales, Australia
Hammond Care
Malvern, Victoria, Australia
Hospital Mutua Terrasa
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
To continue assessing the safety and tolerability of ANAVEX2-73
Time frame: 48 weeks
RSBDQ (REM Sleep Behavior Disorder Screening Questionnaire)
Change from baseline to End of Treatment as measured by RSBDQ
Time frame: 48 weeks
MDS-UPDRS Part III Total Score (Motor Scores)
Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores)
Time frame: 48 weeks
MoCA (Montreal Cognitive Assessment)
Change from baseline to End of Treatment as measured by MoCA
Time frame: 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital del Henares
Coslada, Spain
Clínica Universidad de Navarra (CUN) - Sede Madrid- Servicio de Neurología -
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain